RecruitingNCT05960604

Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients

Observational Study to Evaluate the Pressure Recording Analytical Method Parameters in Patients Susceptible to Post-induction Hypotension Due to Hypertension, Diabetes Mellitus, Cardiovascular Risk Factors, or Major Surgery


Sponsor

Recep Tayyip Erdogan University

Enrollment

660 participants

Start Date

Feb 19, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Perioperative anesthesiologists can benefit from easily obtainable hemodynamic variables detecting or quantifying the lack of an adequate compensatory capacity of the cardiovascular system in order to optimize patient management and improve patient outcomes. Parameters of the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy) of the MostCare system, specifically cardiac cycle efficiency has been proposed as such variables. Yet, their value in anesthesia and especially in hypertensive patients is not studied. The goal of the PRAM-in-HYPO study is to prospectively evaluate the relationship between cardiac reserve and efficiency and cardiovascular risk factors in patients wo will undergo major surgical procedures using the state-of-the-art hemodynamic monitors. Also the investigators aim to build a predictive model to identify patients with decreased cardiac reserve due to hypertension and other cardiovascular risk factors, who are susceptible to post-induction hypotension. The investigators seek to include high-risk patients or patients presenting for major surgery, who are monitored with an advanced hemodynamic monitor to adequately evaluate the differences in cardiac reserve and cardiac efficiency.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a blood pressure monitoring method called PRAM (Pressure Recording Analytical Method) during major surgery to see whether certain blood pressure measurements can predict complications after surgery. The goal is to improve how doctors monitor and manage blood pressure in the operating room. **You may be eligible if...** - You are 18 or older and scheduled for major surgery under general anesthesia lasting more than 2 hours - You need invasive (arterial line) blood pressure monitoring during surgery - You are expected to stay in the hospital for more than 2 days after surgery **You may NOT be eligible if...** - You have a heart rhythm problem (arrhythmia) or require an intra-aortic balloon pump or heart-lung bypass machine - You have severely reduced heart function (ejection fraction below 35%) or advanced heart failure (NYHA Class 3–4) - You are already on vasopressor or inotrope (heart-stimulating) drugs before surgery - You have severe kidney disease or are on dialysis - You are critically ill and need ICU care before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPassive leg raising

All patients who met the inclusion criteria will be placed head down flat and feet up at a 45° angle for 30 seconds. Hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected before, during and after the test until the end of the surgery. The total duration of the intervention (passive leg raising) is 30 seconds. The total duration of hemodynamic parameters recording is expected to be 60-600 minutes.


Locations(5)

Gazi University Medical Faculty, Department of Anesthesiology and Reanimation

Ankara, Turkey (Türkiye)

Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation

Erzurum, Turkey (Türkiye)

Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic

Istanbul, Turkey (Türkiye)

Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation

Istanbul, Turkey (Türkiye)

Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation

Rize, Turkey (Türkiye)

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NCT05960604


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